What is the secret to safely expediting study start-ups? Explore our case study to find out how open dialogue, aligned expectations, and direct communication between Altasciences’ team leads and sponsor contributed to a clinical trial start-up of only 3.5 weeks.

Combining certain Phase 2 studies with the Phase 1 protocol gives you earlier access to data, enabling more informed go/no-go decisions early in the program. This strategy makes it possible to accelerate drug development and better allocate resources.

By completing your trials in Canada, you can accelerate your early phase clinical research by six to nine weeks compared to an IND submission in the U.S.

Discover how ethnobridging streamlines the approval process in Asian markets and addresses potential disparities in drug metabolism between Asian and non-Asian populations.

A recent FDA draft guidance aims to address health disparities and enhance data quality with action plans for greater inclusivity in clinical trials. Explore practical steps to building trust and inclusivity in clinical research.

Choosing the right CRO/CDMO for your first-in-human (FIH) trials enables you to run a successful study that generates high-quality data with speed and ease.

Discover how early clinical cognitive testing and dedicated driving simulation studies can help assess the cognitive functions for safety and efficacy in drug development.

This FAQ list offers clarity on pivotal aspects of your drug development journey, ensuring studies in Canada pave the way for U.S. FDA and EMA submissions.

In this article, we provide a detailed overview of the multiple facets you need to consider during the planning and conduct of your CNS-active drug development.

Discover how the complexity and challenges of bringing ophthalmic therapeutics to market can be mitigated by entrusting your drug development program to an integrated CRO/CDMO partner.

Learn how to identify which cognitive and pharmacodynamic tests are required for novel CNS-active drugs and best practices on conducting them during First-In-Human (FIH) trials.

Learn more about structuring early-phase trials to address population variation and the contributing factors to safe drug administration, both of which are essential to a drug development plan.

Globally recognized consultants discuss how they are addressing the most pressing drug development topics in the ocular field.

Gain valuable insights into the cutting-edge approaches shaping the future of gene and cell therapy delivery, ensuring more effective and efficient translation from discovery to clinical application.

As GLP-1 drugs reshape the market, understanding their potential risks, applications, and economic effects is crucial for professionals in the pharmaceutical and healthcare industries.

<p>Learn how CROs and CDMOs work in tandem to successfully address operational and regulatory challenges for pharmaceutical and biotech companies, and how this can determine study success or failure.</p>

The video dives into the obstacles of the traditional outsourcing relationship between CROs and sponsors, and how Altasciences has broken from tradition to offer an alternative model.

A comprehensive review of optimal timing and methodologies for cognitive and pharmacodynamic testing during first-in-human trials on CNS-active compounds.

Learn about a unique, integrated program management strategy that can lower your costs and reduce program timelines from lead candidate selection to clinical proof-of-concept by up to 40%.

Join our panel of experts for an in-depth review of the FDA's guidance on psychedelic drug development, exploring necessary methodological adaptations for safety, pharmacology, and efficacy.

Experience expedited timelines by conducting trials in Canada. Our expertise in navigating Health Canada's CTA process ensures smooth and efficient approvals.

In this webinar, Altasciences discuss the similarities and differences of conducting early phase research in North America versus other geographic regions.

Watch this video in which Altasciences’ regulatory experts share key insights on Health Canada’s Clinical Trial Application (CTA) regulatory submission process.

Discover the crucial insights and methodological adaptations needed to effectively assess the safety, pharmacology, and efficacy of innovative psychedelic compounds designed for specific medical applications.

Dr. Beatrice Setnik, Altasciences' Chief Scientific Officer, walks through the differences between early and late QT prolongation testing.

Dr. Beatrice Setnik, Chief Scientific Officer at Altasciences, discusses tactics for a successful clinical development pathway for CNS-active drugs.

Altasciences and Sygnature Discovery discuss the clinical and non-clinical studies required for evaluation of abuse risks of psychedelic drugs.

Delve into the key considerations for delivering an integrated preclinical and clinical abuse potential drug development evaluation that meets EMA and FDA regulatory requirements.

This session explores the flexible selection of pharmacodynamic measures to enhance the pharmacology, safety, and efficacy evaluation of a CNS-active drug in early clinical trials.

Learn how ethnic differences can impact the bioavailability of your drug candidate and strategies for the design of your multiregional clinical development program.